Therasense, Inc. v. Becton, Dickinson & Co., — F.3d —-, 2011 U.S. App. LEXIS 10590 (Fed. Cir. 2011) (en banc) (RADER, Newman, Lourie, Linn, Moore & Reyna; O’MALLEY, concurring-in-part & dissenting-in-part; BRYSON, Gajarsa, Dyk & Prost, dissenting) Therasense.05252011.fc

MAJOR ISSUES: inequitable conduct rendering patents unenforceable; raising standards for materiality and intent; “but for” materiality; no “sliding scale”; no materiality required for affirmative egregious misconduct

COMMENTS: In a milestone decision, the Federal Circuit, sitting en banc, reviewed the standard of materiality for the inequitable conduct defense to patent infringement. In a majority opinion for six of the participating eleven judges, Chief Judge Rader “tighten[ed] the standards for finding both intent and materiality in order to redirect a doctrine that has been overused to the detriment of the public.”  On intent, the majority (1) rejected a “sliding scale” approach under which “a weak showing of intent may be found sufficient based on a strong showing of materiality, and vice versa,” and (2) restricted the circumstances under which the necessary intent to deceive the PTO may be inferred.  On materiality, the majority (1) adopted a “but-for” standard of materiality, (2) recognized “an exception in cases of affirmative egregious misconduct,” and (3) eschewed prior decisions that relied on the PTO’s Rule 56 definitions of materiality.

For a preliminary, critical evaluation of Therasense, see below.

CROSS REFERENCES:  On the inequitable conduct defense and its history, see Chisum on Patents 19.03.  For case law on the defense, see Chisum, Patent Law Digest 4000.

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